Movement DisordersNCT01432418
Effectiveness of a Wheelchair Skills Training Program for Power Mobility Users: A Randomized Controlled Trial
A study testing Wheelchair skills training program in people with Movement Disorders, run by Nova Scotia Health Authority at 6 sites in Canada.
Trial summary
This is a 3-year multi-centre, single-blinded, randomized controlled trial (RCT) to test the hypothesis that wheelchair skills training (using a systematic training program called the Wheelchair Skills Training Program) improves wheelchair skills and safety of 144 powered wheelchair users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Movement Disorders
- What is being tested?
- Wheelchair skills training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 6 sitesCanada
- Study dates
- Jun 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- new or experienced powered wheelchair users
- use or are expected to use powered wheelchairs for at least 4 hrs/week
- have access to a powered wheelchair with a suitable range of controller settings (i.e. able to climb a 5cm level change) for testing and training
- equal or greater than 18 years of age
- able to follow directions in either French or English (whichever is in use at the participating site)
- have the potential to operate their powered wheelchairs independently
Show all 12Show fewer
- have room for improvement (in the opinion of the potential participant's clinician)
- requires no more than minimal assistance for communication and auditory comprehension (in the opinion of the potential participant's clinician)
- able to follow 2-step commands
- demonstrate the ability to attend training sessions during the intake session
- competent to provide their own informed consent
- able to be comfortably seated in the powered wheelchairs that will be used for the study (if not their own).
Who cannot join
- use or are expected to use a scooter
- have a rapidly progressive disorder (e.g. amyotrophic lateral sclerosis or terminal cancer)
- have significant visual impairments (legally blind)
- have unstable medical conditions (e.g. angina, seizures)
- have emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, B3H 4K4
University of Western Ontario
London, Ontario, N6G 1H1
Centre de Réadaptation Lucie-Bruneau
Montreal, Quebec, H2H 2N8
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale
Québec, Quebec, G1M 2S8
Toronto Rehab
Toronto, Ontario, M5G 1V7
GFS Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
This is a 3-year multi-centre, single-blinded, randomized controlled trial (RCT) to test the hypothesis that wheelchair skills training (using a systematic training program called the Wheelchair Skills Training Program) improves wheelchair skills and safety of 144 powered wheelchair users. A second objective is to assess the effects of age, sex, training centre, and participant experience on outcomes, assessing the retention of benefits and assessing the impact of training on other important outcomes.
- Conditions
- Movement Disorders
- Being tested
- Wheelchair skills training program
- Keywords
- rehabilitation, wheelchairs, safety, disability evaluation, motor skills
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair skills training programOther
A training program that uses methods based on the rehabilitation, wheelchair, and motor skills literature to teach wheelchair skills.
| Study group | Role | What they receive |
|---|---|---|
| wheelchair training | Experimental | Not described Receives: Other: Wheelchair skills training program |
| Control | No intervention | Standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Wheelchair Skills, WST 4.1 questionnaire version
A measure of what the person 'can do' (capacity), 'does do' (performance), and the safety of various wheelchair skills. The Wheelchair Skills Test (WST) version 4.1 in questionnaire format will be used.
Measured: baseline, 1 month , 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Lee Kirby, Nova Scotia Health Authority
- Investigators
- Lee Kirby, MD, FRCP, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432418
- Sponsor's protocol ID
- 230378
- Other IDs
- CDHA-RS/2012-133
- Status last verified
- May 2016
- First submitted
- 8 Sep 2011
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Wheelchair Skills Training Program for Power Mobility Users: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01432418
- Acronym / sponsor ID
- 230378
- Conditions
- Movement Disorders
- Keywords
- rehabilitation, wheelchairs, safety, disability evaluation, motor skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 3-year multi-centre, single-blinded, randomized controlled trial (RCT) to test the hypothesis that wheelchair skills training (using a systematic training program called the Wheelchair Skills Training Program) improves wheelchair skills and safety of 144 powered wheelchair users. A second objective is to assess the effects of age, sex, training centre, and participant experience on outcomes, assessing the retention of benefits and assessing the impact of training on other important outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wheelchair training | Experimental | Other: Wheelchair skills training program |
| Control | No intervention | –Standard of care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- new or experienced powered wheelchair users
- use or are expected to use powered wheelchairs for at least 4 hrs/week
- have access to a powered wheelchair with a suitable range of controller settings (i.e. able to climb a 5cm level change) for testing and training
- equal or greater than 18 years of age
- able to follow directions in either French or English (whichever is in use at the participating site)
Key exclusion criteria (5 listed)
- use or are expected to use a scooter
- have a rapidly progressive disorder (e.g. amyotrophic lateral sclerosis or terminal cancer)
- have significant visual impairments (legally blind)
- have unstable medical conditions (e.g. angina, seizures)
- have emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheelchair skills training programA training program that uses methods based on the rehabilitation, wheelchair, and motor skills literature to teach wheelchair skills. | Other | wheelchair training |
Primary outcome
Change from baseline in Wheelchair Skills, WST 4.1 questionnaire version
Time frame: baseline, 1 month , 3 months
A measure of what the person 'can do' (capacity), 'does do' (performance), and the safety of various wheelchair skills. The Wheelchair Skills Test (WST) version 4.1 in questionnaire format will be used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- pubmed Canada study resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Kirby, MD, FRCP principal investigator
Nova Scotia Health Authority
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheelchair skills training program in people with Movement Disorders, run by Nova Scotia Health Authority at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Wheelchair Skills, WST 4.1 questionnaire version (time frame: baseline, 1 month , 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.